Implantable Film/Mesh Composite

ABSTRACT

The present disclosure relates to implantable medical devices which include at least one mesh and at least one film attached to the mesh along different portions of the mesh creating at least one aperture between the mesh and the film.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 61/551,118, filed Oct. 25, 2011, the entiredisclosure of which is incorporated by reference herein.

BACKGROUND

1. Technical Field

The present disclosure relates generally to implantable medical devices,and more particularly, to implantable medical devices which include atleast one mesh attached to at least one film, wherein the film has atleast a first and second portion attached to different portions of themesh and third film portion positioned therebetween which is unattachedto the mesh.

2. Background of Related Art

Surgical meshes may be used during both laparoscopic and open surgeryfor repair of many types of defects and injuries. For example, surgicalmeshes are commonly used in the repair of hernias. The meshes may beused to provide support to surrounding tissue.

During hernia repair, a mesh may be placed over the entirety of damagedtissue and some of the healthy tissue surrounding the defect. The meshcan be held in place by a fixation device that attaches the mesh to thesurrounding tissue. A variety of different fixation devices may be usedto anchor the mesh into the tissue. The mesh may further include anadditional layer such as a film, for sustained delivery of analgesicagents to the vicinity of the mesh implant for reduction of acutepost-operative pain. Integration of films to accommodate uniquepatient/anatomical features while maintaining the integrity of thefilm/mesh attachment is desired.

SUMMARY

Accordingly, the present disclosure relates to implantable medicaldevices which include a surgical mesh and a film having at least a firstand second portions attached to the mesh and a third portion positionedbetween therebetween and unattached to the mesh creating an aperturetherebetween. The mesh may generally be a textile or fabric created topromote tissue ingrowth and support injured tissue. The film maygenerally be polymeric in nature and may be intended to further enhancethe ingrowth of tissue into the implant, prevent adhesions ofsurrounding tissue, deliver therapeutic agents and/or simply provideaddition support to the implant. In certain embodiments, the implantablemedical device further includes at least one therapeutic agent. In someembodiments, the implant may include a plurality of: film portionsattached to the mesh; film portions unattached to the mesh; and/orapertures.

In some embodiments, the implantable medical device may include a firstmesh having a first outer edge and a first inner edge, a second meshhaving a second outer edge and a second inner edge, and, a film havingat least a first portion attached to the first outer edge of the firstmesh and at least a second portion attached to the outer edge of thesecond mesh, wherein the first and second inner edges are reversiblyattached.

In other embodiments, the implantable medical device may include a mesh,a first film having a first film portion attached to a first meshportion of the mesh and a second film portion unattached to the mesh,and, a second film having a second film portion attached to a secondmesh portion of the mesh and a second film portion unattached to themesh, wherein the second film portion overlaps the first film portion.

Methods of forming and implanting such devices are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing objects and advantages of the disclosure will become moreapparent from the reading of the following description in connectionwith the accompanying drawings, in which:

FIGS. 1A and 1B are a perspective view and side view, respectively, ofan implantable medical device according to one embodiment described inthe present disclosure;

FIGS. 2A and 2B are a perspective view and side view, respectively, ofan implantable medical device according to another embodiment describedin the present disclosure;

FIGS. 3A and 3B are a perspective view and side view, respectively, ofan implantable medical device according to yet another embodimentdescribed in the present disclosure;

FIGS. 4A and 4B are a perspective view and side view, respectively, ofan implantable medical device according to still another embodimentdescribed in the present disclosure;

FIG. 5 is a side view of an implantable medical device according to oneembodiment described in the present disclosure;

FIG. 6 is a side view of an implantable medical device according toanother embodiment described in the present disclosure;

FIGS. 7A and 7B are side views of an implantable medical deviceaccording to yet another embodiment described in the present disclosure;

FIG. 8A is a perspective view of an implantable medical device accordingto still another embodiment described in the present disclosure;

FIGS. 8B and 8C are side views of the implantable medical device shownin FIG. 8A;

FIGS. 9A and 9B are a perspective view and a side view, respectively, ofan implantable medical device according to yet another embodimentdescribed in the present disclosure;

FIG. 10 is a diagram showing the weave of three sheets forming a medicaldevice according to one embodiment described in the present disclosure;and

FIG. 11 is a diagrammatic side view of a device permitting the formationof spiked naps on the medical device of FIG. 9 according to anotherembodiment described in the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates to implantable medical devices whichinclude a surgical mesh connected to a film with an aperture positionedbetween the mesh and a portion of the film. The film includes a firstand second portion which is attached to a first and second portion ofthe mesh. The film further includes a third or free portion which ispositioned between the first and second film portions which isunattached to and spaced a distance from any portion of the mesh,creating an aperture between the film and the mesh. In certainembodiments, the implantable medical device further includes at leastone therapeutic agent.

By implantable, the medical devices described herein may be positionedfor any duration of time at a location within a body, such as within aportion of the abdominal cavity. Furthermore, the terms “implantation”and “implanted” refer to the positioning, for any duration of time, of amedical device at a location within a body, such as within a portion ofthe abdominal cavity.

The implantable medical devices described herein include at least onesurgical mesh. The surgical mesh described herein may include porousfabrics made from intertwined filaments. The filaments may extendhorizontally and vertically in a manner which produces sections wherethe filaments cross-over one another creating points of commonintersection. The surgical mesh may be woven, non-woven, knitted orbraided. In some embodiments, the filaments may form two-dimensional orthree-dimensional meshes. Some examples of two-dimensional and/orthree-dimensional mesh substrates may be found in U.S. Pat. No.7,021,086, U.S. Pat. No. 6,596,002, U.S. Pat. No. 7,331,199, the entirecontents of which are incorporated by reference herein.

Suitable meshes for use in the present disclosure include, for example,a collagen composite mesh such as PARIETEX™ Composite Mesh (commerciallyavailable from Tyco Healthcare Group LP, d/b/a Covidien). PARIETEX™Composite Mesh is a 3-dimensional polyester weave with a resorbablecollagen film bonded on one side. Another suitable mesh includesParietex Progrip™ self-fixating mesh (also commercially available fromCovidien). Parietex Progrip™ is a polyester mesh which includes polylactic acid (PLA) grip members. Other suitable meshes include those soldunder the names PARIETENE®, PARIETEX™, SURGIPRO™ (all commerciallyavailable from Covidien); PROLENE™ (commercially available from Ethicon,Inc.); MARLEX®, DULEX®, 3D MAX® mesh, PERFIX® plug, VENTRALEX®, andKUGEL® patch (all commercially available from C.R. Bard, Inc.);PROLITE™, PROLITE ULTRA™ (all commercially available from AtriumMedical); COMPOSIX®, SEPRAMESH®, and VISILEX® (all commerciallyavailable from Davol, Inc.); and DUALMESH®, MYCROMESH®, and INFINIT®mesh (all commercially available from W.L. Gore). In certain preferredembodiments, Parietex™ Composite Mesh or Parietex™ Pro-grip may beutilized in accordance with the present invention.

Additionally, meshes within the scope and context of this disclosure mayinclude biologic materials such as allografts (i.e., AlloDerm®Regenerative Tissue Matrix from Lifecell), autografts, and xenografts(i.e., PERMACOL™, from Covidien). In alternate embodiments,processed/purified tissues may also be employed. It should be noted thatallografts, xenografts, and autografts may not comprise intertwinedfilaments, but rather may comprise a scaffold or film construction.

Certain meshes within the scope of the present disclosure may comprisemonofilaments or multi-filaments. In certain embodiments, a plurality ofmulti-filaments may be combined to form yarns. In other embodiments, acore-sheath construction may be employed. It is envisioned that the meshmay be configured to any size and/or shape suitable for hernia repair.

In certain embodiments, such as Parietex™ Composite Mesh or Parietex™Pro-grip, the mesh may be knit on a warp knitting machine, of the tricotor Raschel type, with at least three sheets or warps of yarn and as manyguide bars.

In more detail, a rear bar is threaded, one guide full and one guideempty, with first mono- or multi-filaments 10 of a biocompatible polymeras represented as a solid line in FIG. 10. An intermediate bar isthreaded, one guide full, three guides empty, with second mono- ormulti-filaments 11 of a biocompatible polymer as represented as a brokenline in FIG. 10. The intermediate bar works in such a way as to obtain azigzag openwork pattern between the columns of meshes. Finally, a frontbar is threaded, one guide full, one guide empty, and works in a chainstitch with third mono- or multi-filaments 12 a biocompatible polymer asrepresented by a thin line in FIG. 10. The third filament 12, i.e., achain stitch, imprisons first filament 10 and maintains the length ofthe mesh while contributing to the formation of the mesh with theintermediate sheet formed by the second filament 11. The differentfilaments may form yarns and may be worked according to the followingchart:

Warp Rear bar I Intermediate bar II Front bar III Raschel Front bar IIntermediate bar II Rear bar III 7 3 1 7 2 0 — — — 3 4 0 4 5 1 — — — 0 10 0 — — 4 2 3 3 — 1 0 — 4 5

The rear bar places the first filament or yarn in partial weft under thechain stitch and “thrown” onto the needle not forming a chain stitch.For this reason, at the next row, the needle not forming a chain stitchnot being supplied permits escape of the filament which forms a loop 14a projecting from the front face of the mesh.

The threading—one guide full, three guides empty—in the intermediatebar, associated with the displacement, makes it possible to form a lightground texture, stable in width, and open-worked to permit good tissueintegration.

The mesh 14 thus obtained may be provided with loops 14 a (FIG. 11)which may be perpendicular to one of the mesh surfaces. Loops 14 a mayalso include a rigidity and hold at a right angle which may be obtainedby the rigidity or nerve of the filaments employed. This rigidity may benecessary for the subsequent formation of grip members which ensure agrip function to at least a portion of the implantable medical device.

On leaving the loom, mesh 14 may be subjected to a thermosettingoperation which stabilizes the mesh length and width. The mesh may thenbe subjected to a phase of formation of the grip members consisting, asis shown in FIG. 11, in passing the mesh over a cylinder 13 containingan electrical heating resistor. Mesh 14 is pressed flat on cylinder 13by two pairs of rollers, upstream 15 a, 15 b and downstream 16 a, 16 b,respectively, which are vertically displaceable for controlling thispressing force.

This control as well as that of the temperature of the resistor placedin cylinder 13 and of the speed of movement of mesh 14 across cylinder13 make it possible to melt the head of each of loops 14 a so that eachloop 14 a forms two grip members 17.

Each grip member 17 thus may have a substantially rectilinear bodyprotruding perpendicularly with respect to mesh 14 and, at the free endof this body, a head 17 a of greater width than that of the body. Head17 a has a generally spheroidal shape or a mushroom shape. Grip member17 gives mesh 14 the ability to attach to tissue when implanted. Inaddition, grip members 17 may attach to other portions of mesh 14 whenfolded, rolled or manipulated in any other way. The grip members may bepositioned along any portion of the mesh and in any quantity and/orconfiguration. For example, in some embodiments, the grip members may bepositioned on the same portion of the mesh as the film. In otherembodiments, the grip members may be positioned on a different portionof the mesh which does not include the film.

Alternatively, the mesh may be formed using other methods such as thosewithin the purview of one skilled in the art, including, but not limitedto weaving, knitting, braiding, crocheting, extruding, spraying,casting, molding, and combinations thereof. Meshes formed therefrom maycomprise two or three dimensional constructs.

The implantable devices described herein may be made fromnon-bioabsorbable materials, such as polypropylene, polyethylene,polyethylene terephthalate, polytetrafluoroethylene, and the like. Inone specific embodiment, the mesh may comprise polypropylene orpolyethylene terephthalate.

Alternatively, or in addition to, the implantable devices may comprisebioabsorbable materials. Some non-limiting examples includepolysaccharides such as cellulose, dextran, chitin, chitosan, alginate,pectin, mucilage, pullalan, methylcellulose, carboxymethylcellose,hydroxypropyl methylcellulose, hyaluronic acid (HA), hydroxyethylmethylcellulose, arabinoxylans, bacterial polysaccharides andcombinations thereof. In certain embodiments, the film layer maycomprise carboxymethylcellulose.

Some additional non-limiting examples of bioabsorbable materials used toform the implantable devices include polymers selected from the groupconsisting of aliphatic polyesters; polyamides; polyamines; polyalkyleneoxalates; poly(anhydrides); polyamidoesters; copoly(ether-esters);poly(carbonates) including tyrosine derived carbonates;poly(hydroxyalkanoates) such as poly(hydroxybutyric acid),poly(hydroxyvaleric acid), and poly(hydroxybutyrate); polyimidecarbonates; poly(imino carbonates) such as such as poly (bisphenolA-iminocarbonate and the like); polyorthoesters; polyoxaesters includingthose containing amine groups; polyphosphazenes; poly (propylenefumarates); polyurethanes; polymer drugs such as polydiflunisol,polyaspirin, and protein therapeutics; biologically modified (e.g.,protein, peptide) bioabsorbable polymers; and copolymers, blockcopolymers, homopolymers, blends, and combinations thereof.

More specifically, aliphatic polyesters include, but are not limited to,homopolymers and copolymers of lactide (including lactic acid, D-,L- andmeso lactide); glycolide (including glycolic acid);epsilon-caprolactone, p-dioxanone(1,4-d ioxan-2-one); trimethylenecarbonate(1,3-d ioxan-2-one); alkyl derivatives of trimethylenecarbonate; Δ-valerolactone; β-butyrolactone; γ-butyrolactone;δ-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-d ioxepan-2-one(including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-d ione);1,5-d ioxepan-2-one; 6,6-d imethyl-1,4-d ioxan-2-one; 2,5-diketomorpholine; pivalolactone; α, αdiethylpropiolactone; ethylenecarbonate; ethylene oxalate; 3-methyl-1,4-dioxane-2,5-d ione; 3,3-diethyl-1,4-d ioxan-2,5-dione; 6,8-d ioxabicycloctane-7-one; and polymerblends and copolymers thereof. In one particular embodiment, the filmmay comprise at least one aliphatic polyester.

Other suitable bioabsorbable materials which may be used in theimplantable device include but are not limited to poly(amino acids)including proteins such as collagen (I, II and III), elastin, fibrin,fibrinogen, silk, and albumin; peptides including sequences for lamininand fibronectin (RGD); polysaccharides such as hyaluronic acid (HA),dextran, alginate, chitin, chitosan, and cellulose; glycosaminoglycan;mucilage, pectin; and combinations thereof.

The term “collagen” is meant to include any type of collagen, whethernatural or synthetic, of human or animal origin, such as, for example,enriched human collagen of type I, human collagen of type III, alsoenriched, human collagen of type I+III or of type IV or other collagenssuch as animal collagen of type I or of type I+III. The collagen may beoxidized or non-oxidized.

In certain embodiments, the collagen may be oxidized withoutcrosslinking For example, native collagen may be dipped in an acidsolution and/or washed, to eliminate the telopeptides, notably by pepsindigestion.

The collagen may also be modified by oxidative cleavage. For thispurpose periodic acid or one of its salts can be used, applying thetechnique described by M. TARDY et al. (FR-A-2 601 371 and U.S. Pat. No.4,931,546, the entire contents of which are herby incorporated byreference).

It is recalled briefly that this technique consists of mixing thecollagen in acid solution with a solution of periodic acid or one of itssalts at a concentration of between 1 and 10⁻⁵ M, preferably between 510⁻³ and 10⁻¹ M, at a temperature of between 10 and 25° C. for 10minutes to 72 hours.

This process breaks down some of the collagen's components, these beinghydroxylysine and the sugars, thus creating reactive sites withoutcausing crosslinking.

The oxidative cleavage of collagen allows moderate cross-linking laterin the collagenic material but does not exclude the possibility ofproviding this function by other means of moderate cross-linking, forexample by beta or gamma irradiation, or other agents of moderatecross-linking, for example chemical reagents at suitably low andnon-toxic doses.

For some applications, the polymer film layers described herein mayinclude collagen which is not oxidized or a mixture in any proportionsof non-oxidized and oxidized collagens.

Additionally, synthetically modified natural polymers such as celluloseand polysaccharide derivatives, including alkyl celluloses, hydroxyalkylcelluloses, cellulose ethers, cellulose esters, nitrocelluloses, andchitosan may be utilized. Examples of suitable cellulose derivativesinclude methyl cellulose, ethyl cellulose, hydroxypropyl cellulose,hydroxypropyl methyl cellulose, hydroxybutyl methyl cellulose, celluloseacetate, cellulose propionate, cellulose acetate butyrate, celluloseacetate phthalate, carboxymethyl cellulose (CMC), cellulose triacetate,and cellulose sulfate sodium salt. These may be collectively referred toherein, in embodiments, as “celluloses.”

Both the mesh and/or the film may further consist of at least oneoptional ingredient. Some examples of suitable optional ingredientsinclude emulsifiers, viscosity enhancers, dyes, pigments, fragrances, pHmodifiers, wetting agents, plasticizers, antioxidants, and the like. Theoptional ingredients may represent up to about 10% of the implantablemedical device by weight.

In some embodiments, the film may include at least one plasticizer,i.e., glycerol, PEG, etc. For instance, in some embodiments, the filmmay include a combination of carboxymethylcellulose and glycerol. Inother embodiments, the film may include collagen, and at least one ofPEG and glycerol.

Alternatively, the film may comprise a copolymer of glycolide andcaprolactone. More particularly, the film may contain a copolymer ofabout 10% glycolide and about 90% caprolactone.

In yet alternate embodiments, the film may comprise a copolymer ofglycolide, trimethylene carbonate, caprolactone and lactide. Moreparticularly, the film may contain about 69% glycolide, about 7%trimethylene carbonate, about 17% caprolactone and about 7% lactide.

In yet other embodiments, the film may comprise a copolymer ofglycolide, dioxanone, and trimethylene carbonate. More particularly, thefilm may contain a copolymer of about 60% glycolide, about 14%dioxanone, and about 26% trimethylene carbonate.

The films described herein may be formed by any suitable method known tothose skilled in the art. In certain embodiments, a solution may beformed which includes the suitable polymeric material and any optionalingredients. Polymers solutions described herein include suspensions,emulsions, dispersions and the like. The polymer may represent fromabout 1.0% to about 50% (w/w) in the solution. The solution may be castbulk sheet stock, spray coated using an ultrasonic sprayer, extruded,molded and the like, to form the films described herein.

Suitable solvents which may be in polymer solutions include, withoutlimitation, methylene chloride, chloroform, N-methylpyrrolidone,tetrahydrofuran, dimethylformamide, methanol, ethanol, hexanes, acetoneand combinations thereof.

In some embodiments, the polymer solution may be cast into a filmdirectly on a portion of the mesh surface. In other embodiments, thefilm may be spray coated directly on a portion of the mesh. In stillother embodiments, the film may be formed before being connected to themesh.

In certain embodiments, the film may be created using a sprayingtechnique, such as ultrasonic spraying. Spraying films results in aunique ability to include a high therapeutic payload of a therapeuticagent. For example, the medical device as described herein may befabricated by passing a first solution containing a hydrophobic polymerand a second solution containing a therapeutic agent through anultrasonic spray nozzle to form droplets. The droplets may be mixedwhile falling towards or being deposited onto an inert substrate, suchas silicone sheet, or a portion of the mesh to form a film. In someembodiments, prior to spraying the film, an inert substrate may bepositioned on the portion of the mesh which the film is not meant tobecome fixedly attached to. Thus, upon formation of the film, the filmmay adhere to the portions of the mesh which are not covered by theinert substrate and the film will not fixedly attach to the portions ofthe mesh which are covered by the inert substrate. In yet anotherembodiment, the polymeric film layer may be formed using an ultrasonicspraying nozzle onto an inert substrate.

In some embodiments, the films include a single layer containing ahydrophobic polymer and a therapeutic agent. In other embodiments, thefilms include a first layer containing a hydrophobic polymer and asecond layer containing a therapeutic agent. In still other embodiments,the films include a tri-layer structure wherein a second layercontaining a therapeutic agent is positioned between a first layercontaining a hydrophobic polymer and a third layer containing the sameor different hydrophobic polymer.

In certain embodiments, the hydrophobic polymers of the films mayinclude aliphatic polyesters such as include lactide, glycolide,dioxanone, trimethylene carbonate, and ε-caprolactone. For example, thetherapeutic agents described herein may be combined with copolymers,i.e., random, or block copolymers, of lactide and glycolide or glycolideand ε-caprolactone. Increasing the amount of glycolide may increase thefilms degradation rate. While increasing the amount of lactide and/orcaprolactone may extend the degradation/absorption profile of the film.For example, lactide rich copolymers, i.e., greater than about 50%lactide, may be particularly useful to enhance a particular polymer'ssolubility, such as glycolide.

Suitable therapeutic agents and drugs may be incorporated into theimplantable medical devices described herein. The term “therapeuticagent”, as used herein, is used in its broadest sense and includes anysubstance or mixture of substances that provides a beneficial,therapeutic, pharmacological, and/or prophylactic effect. The agent maybe a drug which provides a pharmacological effect.

The term “drug” is meant to include any agent capable of rendering atherapeutic effect, such as, anti-adhesives, antimicrobials, analgesics,antipyretics, anesthetics (e.g. local and systemic), antiepileptics,antihistamines, anti-inflammatories, cardiovascular drugs, diagnosticagents, sympathomimetics, cholinomimetics, antimuscarinics,antispasmodics, hormones, growth factors, muscle relaxants, adrenergicneuron blockers, antineoplastics, immunogenic agents,immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids,lipopolysaccharides, polysaccharides, platelet activating drugs,clotting factors, and enzymes. It is also intended that combinations ofagents may be used.

Other therapeutic agents, which may be included as a drug include:anti-fertility agents; parasympathomimetic agents; psychotherapeuticagents; tranquilizers; decongestants; sedative hypnotics; sulfonamides;sympathomimetic agents; vaccines; vitamins; antimalarials; anti-migraineagents; anti-parkinson agents such as L-dopa; anti-spasmodics;anticholinergic agents (e.g., oxybutynin); antitussives;bronchodilators; cardiovascular agents, such as coronary vasodilatorsand nitroglycerin; alkaloids; analgesics; narcotics such as codeine,dihydrocodeinone, meperidine, morphine and the like; non-narcotics, suchas salicylates, aspirin, acetaminophen, d-propoxyphene and the like;opioid receptor antagonists, such as naltrexone and naloxone;anti-cancer agents; anti-convulsants; anti-emetics; antihistamines;anti-inflammatory agents, such as hormonal agents, hydrocortisone,prednisolone, prednisone, non-hormonal agents, allopurinol,indomethacin, phenylbutazone and the like; prostaglandins and cytotoxicdrugs; chemotherapeutics; estrogens; antibacterials; antibiotics;anti-fungals; anti-virals; anticoagulants; anticonvulsants;antidepressants; and immunological agents.

Other examples of suitable agents, which may be included in the filmsdescribed herein include, for example, viruses and cells; peptides,polypeptides and proteins, as well as analogs, muteins, and activefragments thereof; immunoglobulins; antibodies; cytokines (e.g.,lymphokines, monokines, chemokines); blood clotting factors; hemopoieticfactors; interleukins (e.g., IL-2, IL-3, IL-4, IL-6); interferons (e.g.,β-IFN, α-IFN and γ-IFN); erythropoietin; nucleases; tumor necrosisfactor; colony stimulating factors (e.g., GCSF, GM-CSF, MCSF); insulin;anti-tumor agents and tumor suppressors; blood proteins such as fibrin,thrombin, fibrinogen, synthetic thrombin, synthetic fibrin, syntheticfibrinogen; gonadotropins (e.g., FSH, LH, CG, etc.); hormones andhormone analogs (e.g., growth hormone); vaccines (e.g., tumoral,bacterial and viral antigens); somatostatin; antigens; blood coagulationfactors; growth factors (e.g., nerve growth factor, insulin-like growthfactor); bone morphogenic proteins; TGF-B; protein inhibitors; proteinantagonists; protein agonists; nucleic acids such as antisensemolecules, DNA, RNA, and RNAi; oligonucleotides; polynucleotides; andribozymes.

Some specific non-limiting examples of water-soluble drugs that may beused in the present polymeric films include, lidocaine, bupivacaine,capsaicin, tetracaine, procaine, dibucaine, sirolimus, taxol,chlorhexidine, polyhexamethylene, thiamylal sodium, thiopental sodium,ketamine, flurazepam, amobarbital sodium, phenobarbital,bromovalerylurea, chloral hydrate, phenytoin, ethotoin, trimethadione,primidone, ethosuximide, carbamazepine, valproate, acetaminophen,phenacetin, aspirin, sodium salicylate, aminopyrine, antipyrine,sulpyrine, mepirizole, tiaramide, perixazole, diclofenac, anfenac,buprenorphine, butorphanol, eptazocine, dimenhydrinate, difenidol,dl-isoprenaline, chlorpromazine, levomepromazine, thioridazine,fluphenazine, thiothixene, flupenthixol, floropipamide, moperone,carpipramine, clocapramine, imipramine, desipramine, maprotiline,chlordiazepoxide, clorazepate, meprobamate, hydroxyzine, saflazine,ethyl aminobenzoate, chlorphenesin carbamate, methocarbamol,acetylcholine, neostigmine, atropine, scopolamine, papaverine,biperiden, trihexyphenidyl, amantadine, piroheptine, profenamine,levodopa, mazaticol, diphenhydramine, carbinoxamine, chlorpheniramine,clemastine, aminophylline, choline, theophylline, caffeine, sodiumbenzoate, isoproterenol, dopamine, dobutamine, propranolol, alprenolol,bupranolol, timolol, metoprolol, procainamide, quinidine, ajmaline,verapamil, aprindine, hydrochlorothiazide, acetazolamide, isosorbide,ethacrynic acid, captopril, enalapril, delapril, alacepril, hydralazine,hexamethonium, clonidine, bunitrolol, guanethidine, bethanidine,phenylephrine, methoxamine, diltiazem, nicorandil, nicametate,nicotinic-alcohol tartrate, tolazoline, nicardipine, ifenprodil,piperidinocarbamate, cinepazide, thiapride, dimorpholamine,levallorphan, naloxone, hydrocortisone, dexamethasone, prednisolone,norethisterone, clomiphene, tetracycline, methyl salicylate,isothipendyl, crotamiton, salicylic acid, nystatin, econazole,cloconazole, vitamin B₁, cycothiamine, vitamin B₂, vitamin B₃, vitaminB₅, vitamin B₆, vitamin B₇, vitamin B₉, vitamin B₁₂, vitamin C,nicotinic acid, folic acid, nicotinamide, calcium pantothenate,pantothenol, panthetin, biotin, ascorbic acid, tranexamic acid,ethamsylate, protamine, colchicine, allopurinol, tolazamide, glymidine,glybuzole, metoformin, buformin, orotic acid, azathioprine, lactulose,nitrogen mustard, cyclophophamide, thio-TEPA, nimustine, thioinosine,fluorouracil, tegafur, vinblastine, vincristine, vindesine, mitomycin C,daunorubicin, aclarubicin, procarbazine, cisplatin, methotrexate,benzylpenicillin, amoxicillin, penicillin, oxycillin, methicillin,carbenicillin, ampicillin, cefalexin, cefazolin, erythromycin,kitasamycin, chloramphenicol, thiamphenicol, minocycline, lincomycin,clindamycin, streptomycin, kanamycin, fradiomycin, gentamycin,spectinomycin, neomycin, vanomycin, tetracycline, ciprofloxacin,sulfanilic acid, cycloserine, sulfisomidine, isoniazid, ethambutol,acyclovir, gancyclovir, vidabarine, azidothymidine, dideoxyinosine,dideoxycytosine, morphine, codeine, oxycodone, hydrocodone, cocaine,pethidine, fentanyl, polymeric forms of any of the above drugs and anycombinations thereof. Further, water-soluble drugs may not need beconverted to a salt form, i.e., tetracycline hydrochloride, orbupivacaine hydrochloride. In some embodiments, the therapeutic agentmay include an anesthetic, i.e., bupivacaine, bupivacaine hydrochloride,lidocaine, benzocaine, and the like.

Although the above therapeutic agents have been provided for thepurposes of illustration, it should be understood that the presentdisclosure is not so limited. In particular, although certaintherapeutic agents are specifically referred to above, the presentdisclosure should be understood to include analogues, derivatives andconjugates of such agents.

The therapeutic agent may be combined with any portion of the medicaldevice, including the mesh and/or the film. In some embodiments, thetherapeutic agent may be included in the polymeric film to providesustained release of the therapeutic agent following implantation.Because the film may include a high payload of therapeutic agent, thepolymeric films may provide sustained release of the agent for longerperiods of time.

Turning now to Figs. lA and 1B, implantable medical device 100 isillustrated including film 110 at least partially attached to mesh 120.First and second film portions 110 a and 110 b are shown attached tofirst and second mesh portions 120 a and 120 b, respectively. Third filmportion 110 c is positioned between first and second film portions 110a, 110 b and third film portion 110 c is unattached and/or free of anyportion of mesh 120 thereby creating aperture 130 between third filmportion 110 c and mesh 120. The third portion 110 c is spaced a distancefrom the mesh and the spacing distance may vary depending onapplication. It is envisioned that tubular tissues, such as theesophagus, intestines, blood vessels, and/or non-tubular tissues, suchas the spermatic chord, ligaments, tendons and the like may bepositioned within the aperture between the film and the mesh.

In FIGS. 2-4, the implantable medical devices are illustrated includinga film which extends from at least a first corner to a second corner ofthe mesh. For instance, in FIGS. 2A-2B, film 210 includes first filmportion 210 a attached to first mesh corner 220 a and second filmportion 210 b attached to second mesh corner 220 b. Third film portion210 c extends between first and second film portions 210 a, 210 b,respectively, and is unattached to/free from and in certain embodiments,spaced a distance from of any portion of mesh 220 thereby creatingaperture 230 between third film portion 210 c and mesh 220 and extendingdiagonally from first mesh corner 220 a to second mesh corner 220 b. Insuch an embodiment, third and fourth mesh corners 220 c and 220 d areshown free of any film.

In FIGS. 3A-3B, film 310 includes a plurality of film portions 310 a-dattached to a plurality of corners 320 a-d of mesh 320 with a centralfilm portion 310 e positioned centrally between the plurality of filmportions 310 a-d and unattached of any portion of mesh 320 therebycreating aperture 330.

In still another embodiment as depicted in FIGS. 4A-4B, implantablemedical device 400 includes first and second film 410 and 440,respectively, partially attached to mesh 420. First and second portions410 a and 410 b, respectively, of first film 410 are attached to firstand second mesh corners 420 a and 420 b, respectively. Third portion 410c of first film 410 extends between first and second portions 410 a and410 b and is unattached and/or free of any portion of mesh 420 therebycreating first aperture 430 a between first film 410 and mesh 420 andextending diagonally from first mesh corner 420 a to second mesh corner420 b. In addition, first and second portions 440 a and 440 b,respectively, of second film 440 are attached to third and fourth meshcorners 420 c and 420 d, respectively. Third portion 440 c of secondfilm 440 extends between first and second portions 440 a and 440 b ofsecond film 440 and is unattached and/or free of any portion of mesh 420and first film 410 thereby creating second aperture 430 b between secondfilm 440 and first film 410 and/or mesh 420 and extending diagonallyfrom third mesh corner 420 c to fourth mesh corner 420 d. In such anembodiment, the plurality of films and/or apertures may be useful increating an implant capable of supporting tissue in multiple planesand/or directions. For examples, a first tissue type may be positionedwithin first aperture 430 a while a second tissue type may be positionedwithin second aperture 430 b with third portion 410 c of first film 410positioned therebetween.

Although the devices previously described herein include a film portionwhich is free of the mesh, in some embodiments, the devices may furtherinclude an additional film layer positioned along the surface of themesh. As illustrated in FIGS. 5 and 6, this additional film layer may bepositioned along any surface of the mesh. For instance, as shown in FIG.5, second film layer 550 may be positioned along surface 525 of mesh 520between third film portion 510 c and mesh 520. In such an embodiment,aperture 530 may be at least partially encased by film materials whichare supported on at least one side by mesh 520. This type of implant maydeliver a therapeutic agent to all sides of the tissue surrounded by thefilm materials when the therapeutic agent is included in the filmmaterials. In other embodiments, the additional second film layer mayalternatively, or in combination with, be positioned on a surface of themesh opposite the aperture as depicted in FIG. 6, wherein aperture 630is shown on a first surface 620 a of mesh 620 and additional surfacefilm layer 650 is shown on a second surface 620 b of mesh 620 oppositefirst surface 620 a.

In still other embodiments, the implantable medical devices describedherein may include a plurality of apertures positioned between the filmlayer and the mesh. For example, as shown in FIGS. 7A and 7B, film 710includes a plurality of attached film portions 710 a attached to mesh720 and a plurality of unattached film portions 710 b unattached and/orfree of mesh 720 with a plurality of apertures 730 positionedtherebetween. The unattached film portion 710 b may be spaced a distancefrom mesh 720. The unattached film portions 710 b may be spaced varyingdistances from the mesh to accommodate different sized and dimensionedorgans. Additionally, it is envisioned that such a design may increasethe surface area of film 710 along a given area of mesh 720 to interactwith tissue when implanted. It is further envisioned that the increasein surface interaction between the film and the tissue may be useful indelivering higher payloads of a therapeutic agent without increasing thesurface area of the delivery device. For example, as shown in FIG. 7B,upon implantation, the tissue may apply pressure to the implant andcausing film 710 to flatten. In embodiments wherein the film includes atherapeutic agent, such a design allows for the delivery of an increasedamount of the agent without adding the additional biocompatible materialof the mesh device, which may often be made of a non-absorbable andpotentially inflammatory-inducing material.

In yet other embodiments, the medical devices described herein mayfurther include at least one layer which is capable of being separatedto allow for a tissue to be passed therethrough and be positioned withinthe aperture. For example, as shown in FIGS. 8A-8C, implant 800 includesa film 810 attached to a first mesh 820 and a second mesh 821. The film810 has a first portion 810 a attached to a first outer edge of thefirst mesh 820 and a second portion 810 b attached to a second outeredge of the second mesh 821. The first and second meshes 820 and 821 areremovably affixed or connected to one another. First and second mesh 820and 821 each include an outer edge or 820 a and 821 a and an inner edge820 b and 821 b, wherein the inner edges 820 b and 821 b of the firstand second mesh overlap. The inner edge portions of the first and secondmesh may be removably or reversibly attached via a connector, such as anadhesive, suture, clip, grip-member and/or barb. As shown in FIGS. 8Band 8C, a plurality of grip-members 850 are positioned along inner edge821 b of second mesh 821 to removably attach the two mesh portionstogether. It is envisioned that such a mesh may be peeled apart tocreate an opening for the passage of tissue and then reattached with thetissue positioned within the aperture of the implant between the filmand the mesh. It is further envisioned that the connector, i.e.,grip-member or barb, may be positioned on either or both of the firstand second mesh.

In another embodiment, shown in FIG. 9, an implantable device 900 mayinclude a first mesh portion 920 a attached to first film 910 and secondmesh portion 920 b attached to second film 911, wherein first and secondfilms 910 and 911 are reversibly attached. First and second films 910and 911 each include a first outer edge 910 a and second outer edge 911a and a first inner edge 910 b and second inner edge 911 b, wherein thesecond inner edge overlaps the first inner edge. The inner perimeterportions of the first and second films may be reversibly attached via aconnector, such as an adhesive, suture, clip and/or barbs. For instance,an adhesive or clip may be positioned along the inner perimeter of atleast one of the first and second films to removably attach the twofilms together. It is envisioned that such films may be peeled apart tocreate an opening for the passage of tissue and then reattached with thetissue positioned within the aperture of the implant between the filmand the mesh.

Although shown previously as generally square and/or rectangular inshape, the implants described herein including the film, and the meshmay be of any shape and in any combination of shapes.

The implants described herein may be useful in many endoscopic,laparoscopic, arthroscopic, endoluminal, transluminal, and/or opensurgical procedures. Some examples include hernia repair, repair ofvaginal prolapse, ligament repair, tendon repair, and the like. Althoughthe polymeric films described herein may be made from ay biocompatiblematerials, in certain procedures, the film layers may be made fromanti-adhesive materials. For example, when implanting the medicaldevices described herein into tissue near Cooper's ligament, it might beuseful to have the flexibility to wrap around or surround the ligament,or any other sensitive tissue such as the spermatic cord, tendons,intestinal tissue, etc.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, in embodiments the medicaldevice may rolled prior to being delivered into the body via a cannula,trocar or laparoscopic delivery device. In another example, the medicaldevices described herein may be sterilized and packaged into using anysuitable sterilization process, i.e., gamma radiation, and any suitablemedical device package, i.e., a foil pouch, peelable container, Tyvek®package, and/or an injectable medical device package. In still otherexamples, the implants described herein may include more than one film,and/or mesh along any surface of the mesh and/or film. Thus, thoseskilled in the art will envision other modifications within the scopeand spirit of the claims.

What is claimed is:
 1. An implantable medical device comprising: a mesh,a first film having a first outer edge attached to a first portion ofthe mesh and a first inner edge unattached to the mesh, and a secondfilm having a second outer edge attached to a second portion of the meshand a second inner edge unattached to the mesh, wherein the second inneredge overlaps the first inner edge.
 2. The implantable medical device ofclaim 1 further comprising at least one connector.
 3. The implantablemedical device of claim 2 wherein the connector reversibly attaches thesecond inner edge and the first inner edge.
 4. The implantable medicaldevice of claim 2, wherein the connector comprises an adhesive.
 5. Theimplantable medical device of claim 1, wherein at least one of the firstand second films comprise a biodegradable material.
 6. The implantablemedical device of claim 1, wherein at least one of the first and secondfilms comprise an aliphatic polyester.
 7. The implantable medical deviceof claim 1 wherein the film comprises a copolymer of glycolide andcaprolactone.
 8. The implantable medical device of claim 1 wherein thefilm comprises a copolymer of glycolide, trimethylene carbonate,caprolactone and lactide.
 9. The implantable medical device of claim 1wherein the film comprises a copolymer of glycolide, dioxanone, andtrimethylene carbonate.
 10. The implantable medical device of claim 1,wherein the mesh comprises a non-bioabsorbable material.
 11. Theimplantable medical device of claim 1, wherein the mesh comprises anon-bioabsorbable polyester.
 12. The implantable medical device of claim11, wherein the mesh comprises polypropylene.
 13. The implantablemedical device of claim 1, wherein the mesh comprises an animal-derivedtissue.
 14. The implantable medical device of claim 1, wherein the meshcomprises an allograft or a xenograft.
 15. The implantable medicaldevice of claim 1 further comprising at least one therapeutic agent. 16.The implantable medical device of claim 14 wherein the at least onetherapeutic agent comprises a drug selected from the group consisting oflidocaine, bupivacaine, capsaicin, tetracaine, procaine, dibucaine,sirolimus, taxol, chlorhexidine, polyhexamethylene, thiamylal sodium,thiopental sodium, ketamine, flurazepam, amobarbital sodium,phenobarbital, bromovalerylurea, chloral hydrate, phenytoin, ethotoin,trimethadione, primidone, ethosuximide, carbamazepine, valproate,acetaminophen, phenacetin, aspirin, sodium salicylate, aminopyrine,antipyrine, sulpyrine, mepirizole, tiaramide, perixazole, diclofenac,anfenac, buprenorphine, butorphanol, eptazocine, dimenhydrinate,difenidol, dl-isoprenaline, chlorpromazine, levomepromazine,thioridazine, fluphenazine, thiothixene, flupenthixol, floropipamide,moperone, carpipramine, clocapramine, imipramine, desipramine,maprotiline, chlordiazepoxide, clorazepate, meprobamate, hydroxyzine,saflazine, ethyl aminobenzoate, chlorphenesin carbamate, methocarbamol,acetylcholine, neostigmine, atropine, scopolamine, papaverine,biperiden, trihexyphenidyl, amantadine, piroheptine, profenamine,levodopa, mazaticol, diphenhydramine, carbinoxamine, chlorpheniramine,clemastine, aminophylline, choline, theophylline, caffeine, sodiumbenzoate, isoproterenol, dopamine, dobutamine, propranolol, alprenolol,bupranolol, timolol, metoprolol, procainamide, quinidine, ajmaline,verapamil, aprindine, hydrochlorothiazide, acetazolamide, isosorbide,ethacrynic acid, captopril, enalapril, delapril, alacepril, hydralazine,hexamethonium, clonidine, bunitrolol, guanethidine, bethanidine,phenylephrine, methoxamine, diltiazem, nicorandil, nicametate,nicotinic-alcohol tartrate, tolazoline, nicardipine, ifenprodil,piperidinocarbamate, cinepazide, thiapride, dimorpholamine,levallorphan, naloxone, hydrocortisone, dexamethasone, prednisolone,norethisterone, clomiphene, tetracycline, methyl salicylate,isothipendyl, crotamiton, salicylic acid, nystatin, econazole,cloconazole, vitamin B₁, cycothiamine, vitamin B₂, vitamin B₃, vitaminB₅, vitamin B₆, vitamin B₇, vitamin B₉, vitamin B₁₂, vitamin C,nicotinic acid, folic acid, nicotinamide, calcium pantothenate,pantothenol, panthetin, biotin, ascorbic acid, tranexamic acid,ethamsylate, protamine, colchicine, allopurinol, tolazamide, glymidine,glybuzole, metoformin, buformin, orotic acid, azathioprine, lactulose,nitrogen mustard, cyclophophamide, thio-TEPA, nimustine, thioinosine,fluorouracil, tegafur, vinblastine, vincristine, vindesine, mitomycin C,daunorubicin, aclarubicin, procarbazine, cisplatin, methotrexate,benzylpenicillin, amoxicillin, penicillin, oxycillin, methicillin,carbenicillin, ampicillin, cefalexin, cefazolin, erythromycin,kitasamycin, chloramphenicol, thiamphenicol, minocycline, lincomycin,clindamycin, streptomycin, kanamycin, fradiomycin, gentamycin,spectinomycin, neomycin, vanomycin, tetracycline, ciprofloxacin,sulfanilic acid, cycloserine, sulfisomidine, isoniazid, ethambutol,acyclovir, gancyclovir, vidabarine, azidothymidine, dideoxyinosine,dideoxycytosine, morphine, codeine, oxycodone, hydrocodone, cocaine,pethidine, fentanyl, polymeric forms of any of the above drugs and anycombinations thereof.
 17. The implantable medical device of claim 14wherein the at least one therapeutic agent comprises is selected fromthe group consisting of bupivacaine and bupivacaine hydrochloride.